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510(k) K200530

Device
AMICUS Separator System
Applicant
Fresenius Kabi AG
510(k) number
K200530
Product code
GKT  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-11
Date received
2020-03-02
Regulation
864.9245
Classification name
Separator, Automated, Blood Cell, Diagnostic
Medical specialty
Hematology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kim Forch
Address
3 Corporate Dr. Lake Zurich IL US 60047 60047

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GKT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc2016-11-23
K822521AUTOMATED BLOOD CELL SEPARATORCryosan, Inc.1982-09-30
K820396AUTOMATED BLOOD CELL SEPAR. DISP. SFTWRPheragen Technology Corp.1982-04-27
K801233CELLTRIFUGE IITravenol Laboratories, S.A.1980-10-31
K791106STERILE, DISPOSABLE CENTRIFUGE BOWLTravenol Laboratories, S.A.1979-08-10
K790105TERUMO IMUGARDTerumo America, Inc.1979-05-24
K781803FILTER, EYRPUR DISPOSABLE LEUKOCITEMetrix Teknika, Inc.1979-01-17
K771258BLOOD CELL SEPARATOR 2997Intl. Business Machines1977-09-06
K760856BLOOD CELL PROCESSOR MODEL 2 IBM 2991Intl. Business Machines1977-01-10

Legacy Summary#

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FDA Review#

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